HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis

NCT05765513 | Completed DMC

• 1 other identifier: hui20050910
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to research the treatment of 35 kDa hyaluronan fragment HA35 for Mild periodontitis and associated with gingival discomfort or itchiness.

Conditions

Periodontitis

Keywords

35 kDa low molecular hyaluronan fragment; HA35; Tissue permeability; Intra-pocket injection; Gingival redness and bleeding

Outcome Measures

Primary Outcomes (1)

• Gingival discomfort scores

  This study used a modified pain scale to assess gingival discomfort or itching relief. This quantitative assessment represents the degrees of relief of gingival discomfort. Each patient rated their gingival discomfort or itching on a scale of 0 to 10. 0 means "no gingival discomfort or itching" and 10 means "worst gingival discomfort or itching". Pain intensity levels were assessed before and after 7 days of treatment.

  7 days

Secondary Outcomes (2)

• The scores of reduction in the extent of gingival redness and swelling and the reduction in gingival bleeding.

  7 days

• The scores of reduction in gingival bleeding.

  7 days

Study Arms (1)

35kDa hyaluronan fragment HA35 injection

EXPERIMENTAL

The investigator injected 35kDa hyaluronan fragment HA35 into the periodontal pocket in a single dose of 100 mg.The distribution of injection amount was determined by the location of gingival inflammation.

Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)

Interventions

HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) DRUG

The clinical effects of gingival discomfort oritching, redness and swelling, and bleeding from the probing were observed and recorded in patients before and after 7 days of treatment.

Also known as: HA35

35kDa hyaluronan fragment HA35 injection

Eligibility Criteria

• Age: 32 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild periodontitis and associated with gingival discomfort or itchiness.
• Patient \> 18 years old.
• Systemically healthy individuals

You may not qualify if:

• Patients who take Anticoagulants or Antiplatelet Agents
• Pregnant or breastfeeding women
• Patient having expressed his opposition to participate in the research.

Sponsors & Collaborators

• Dove Medical Press Ltd: lead

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

Related Publications (2)

• APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286

  BACKGROUND

• Jia X, Shi M, Wang Q, Hui J, Shofaro JH, Erkhembayar R, Hui M, Gao C, Gantumur MA. Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35). J Inflamm Res. 2023 Jan 13;16:209-224. doi: 10.2147/JIR.S393495. eCollection 2023.

  PMID: 36686276 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Periodontitis; Hemorrhage

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: an open-label, single-arm clinical study comparing pre- and post-treatment effects
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: an open-label, single-arm clinical study comparing pre- and post-treatment effects

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 13, 2023
• Study Start: February 2, 2023
• Primary Completion: July 20, 2023
• Study Completion: August 11, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)